FDA approves Glenmark Topmax bioequivalent capsules

Mumbai: Glenmark Pharmaceuticals Ltd. (Glenmark) made an announcement on receiving final approval from the United States Food & Drug Administration (U.S. FDA) for Topiramate Capsules USP, 15 mg and 25 mg, which is used in treatment of seizures.

The Topiramate capsules meets the quality standards of US pharmacopeia (USP) and have been determined by the FDA to be bioequivalent and therapeutically equivalent to Topamax Capsules, 15 mg and 25 mg of Janssen Pharmaceuticals, Inc., and will be distributed in the US by Glenmark Pharmaceuticals Inc., USA.

Currently the pharma company has 50 ANDA’s pending approval with the U.S. FDA and in addition to these internal filings, it is looking to explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio, Glenmark said.

IQVIA sales data for the 12-month period ending May 2024, shows that the annual sales of Topamax capsules, 15 mg and 25 mg, stand at approximately $21.9 million, it added